Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions

Stopped early

Conditions studied: Tibia Fracture Non Union Bone

In brief

The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

Key facts

Study ID

NCT00726193

Run by

Zimmer Biomet

People needed

4

Starts

2006-06-01

Expected to finish

2008-04-01

Last updated by the study team

2019-01-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of a tibia nonunion.
• Male or female between ages of 18 and 75 years old, inclusive

You may not qualify if…

• Subject has open wounds or underlying osteomyelitis.
• Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points.
• If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.
• Subject has an implanted unipolar pacemaker.
• Subject has active cancer.
• Subject has severe peripheral vascular disease (ABI <0.4)

Where it is running

• Orthopedic Foot and Ankle Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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